Clinical Nurse_Care Coordinator

PPGNHAIK•Honolulu, HI

8h•$35 - $59

About The Position

The Clinical Nurse Care Coordinator serves as the primary study coordinator for specified clinical studies and assists with implementing other studies. The role recruits, screens, schedules, and enrolls research participants; obtains informed consent; collects and enters study data; and supports study startup, monitoring, and closeout. It also includes patient-care responsibilities within the employee’s scope and as required by study tasks. The coordinator works with the Clinical Research Manager, Director of Research/Principal Investigator, sponsors, CROs, IRBs, and health center staff. For assigned trials, the coordinator leads study startup, training, regulatory documentation, and day-to-day operations across multiple health centers. The position also performs health center tasks and follows applicable research, safety, infection-control, privacy, and organizational policies. A Medical Assistant certification or Medical Assistant registration with phlebotomy must be maintained.

Requirements

Bachelor’s degree in life sciences or a health-related field, or an equivalent combination of professional degree and work experience.
At least 2 years of experience in healthcare or a healthcare-related field.
At least 1 year of experience in medical research or research-related activities.
Proficient computer and software skills, including knowledge of Microsoft Office and EPIC.
Excellent written and verbal communication skills.
Self-motivated and detail-oriented.
Maintain either Medical Assistant certification or Medical Assistant registration with phlebotomy.

Nice To Haves

Medical Assistant certification with phlebotomy is preferred.

Responsibilities

Coordinate and support research projects and contribute to study planning and implementation according to study protocols.
Serve as research coordinator for studies at multiple locations, including recruiting, screening, scheduling, enrolling participants, obtaining informed consent, and collecting data and samples.
Coordinate study enrollment with health center managers and patient care team leads, and collaborate with health center staff to integrate study activities into clinic workflow.
Provide direct patient care and assist clinicians with medical workup as needed and when qualified, including obtaining and processing blood, urine, and swab specimens and arranging specimen shipment.
Complete study data collection and entry and ensure the quality of case report forms and source documents.
Lead startup, training, documentation, and daily study operations for assigned clinical trials, including IVD sample collection, medical device, and drug studies.
Assist with staff training on study protocols, informed consent, and other study tasks.
Create source documents and recruitment materials under the guidance of the Clinical Research Manager.
Communicate regularly with sponsors, CROs, IRBs, and the Principal Investigator, and document PI oversight responsibilities appropriately.
Complete IRB submissions and documentation, including applications, continuing reviews, and closeouts.
Maintain study files, regulatory documents, binders, databases, and study-related correspondence.
Manage study supplies and ordering to support enrollment and project timelines.
Perform health center tasks, such as preparing exam rooms, escorting clients to exam rooms, and assisting clinicians.
Follow universal precautions, sterile technique, hazardous-waste disposal, infection and exposure control procedures, and applicable OSHA, WISHA, CLIA, PPFA, and PPGNHAIK policies and procedures.
Protect patient privacy and confidentiality and comply with HIPAA standards.
Follow health center policies and procedures and report needed changes according to PPGNHAIK guidelines.
Maintain current Good Clinical Practice (GCP), Human Subjects Research, and IATA credentials or training, and stay current with PPFA and PPGNHAIK research SOPs and guidelines.
Maintain Medical Assistant certification or Medical Assistant registration with phlebotomy.
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